| Trial ID: | L3328 |
| Source ID: | NCT01785524
|
| Associated Drug: |
Beetroot Juice (Beet-It Stamina Shot) And Exercise Training
|
| Title: |
Dietary Nitrate and Exercise to Augment Exercise Training Benefits in Subjects With DM+PAD
|
| Acronym: |
DM+PAD
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01785524/results
|
| Conditions: |
Peripheral Arterial Disease|Type II Diabetes Mellitus
|
| Interventions: |
DRUG: Beetroot Juice (Beet-It Stamina Shot) and Exercise Training|OTHER: Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training
|
| Outcome Measures: |
Primary: Change in Exercise Capacity - Maximal Oxygen Capacity (VO2peak), Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of peak oxygen consumption, Baseline & 16 Weeks|Change in Exercise Capacity - Time to Exhaustion (TTE), Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test for determination of Time to Exhaustion (TTE), Baseline & 16 Weeks|Change in Exercise Capacity - Claudication Onset Time (COT), Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test for determination of Claudication Onset Time (COT), Baseline & 16 Weeks | Secondary: Change in Functional Ability, Six-Minute Walk test. This test simple and practical assessment of functional capacity. The test measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes. The test is self-paced and assesses the submaximal level of functional capacity. The subjects choose their own intensity and are allowed to stop and rest if necessary during the test., Baseline and 16 Weeks|Change in Angiogenesis, Gastrocnemious muscle biopsy will be performed to measure the number of capillaries per fibre as a marker of change in angiogenesis between groups., Baseline and 16 weeks|Change In Vascular Function, Vascular Function will be measured as the Brachial artery flow-mediated dilation (BAFMD), Baseline and 16 weeks
|
| Sponsor/Collaborators: |
Sponsor: Duke University | Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
18
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-02
|
| Completion Date: |
2014-11
|
| Results First Posted: |
2016-01-05
|
| Last Update Posted: |
2017-07-27
|
| Locations: |
Duke Diet & Fitness Center, Durham, North Carolina, 27710, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01785524
|
